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OpenTrials
Completed

NCT Number: NCT05699291

Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.

The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital privé des Peupliers

Paris, France

About this study

The main objective is to evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital.

The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications.

This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 or over, having given her oral non-objection ;
  • Patient with histologically proven breast cancer ;
  • Patient eligible for the sentinel lymph node technique by Indocyanine Green or isotopes.

Exclusion criteria

  • Patient who has expressed her opposition to the use of her medical data ;
  • Patient under legal protection, guardianship or curatorship ;
  • Pregnant patient ;
  • Patient not affiliated to a social security scheme.

Treatment and study plan

Sentinel node detection technique

Other

Patients cared for by a surgeon for histologically proven breast cancer and for whom an indication for detection of the sentinel lymph node is posed.

Primary outcomes

  1. Average direct costs of the two techniques assessed (Indocyanine Green and isotopes)

    Time frame: 1 month

    To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of the health insurance and the hospital.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.

Acronym: FLUOBREAST-2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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